Job Description Summary

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through March 31, 2026.

Job Summary:
The Sr. Staff Quality Specialist participates and may lead the development, implementation, and maintenance of the  Quality Management System. The individual in this role must work cross functionally both horizontally and vertically within the organization.

Job Responsibilities: 

• Responsible for managing all aspects of Quality Planning to ensure timely completion of deliverables and closure of Quality Plans

• Proactively engage stakeholders to drive consensus and resolve issues in a timely fashion

• Knowledgeable in verification/ validation process, risk management, design controls, and quality compliance areas to drive technical discussions and remove roadblocks

• Take a leading role in the development, implementation and maintenance of Quality System processes required for compliance to FDA 21 CFR 820, MDSAP, ISO 13485, and ISO 9001. 

• Work collaboratively with functional teams to guide and/or facilitate QMS requirements, Continuous Improvement, and Audit Support.

• Facilitate Continuous Improvement projects and investigations including data analysis, root cause analysis and development of action plans to support the QMS.

• Coordinate or lead Quality related projects. Maintain and manage positive working relationships both vertically and horizontally within the organization while leading and/or assisting in all stages of Quality Management System activity and projects.

• Participate or lead other Quality and Transition Projects.

Education and Experience:

• Bachelor of Arts (BA), Bachelor of Science (BS) in related field

• Minimum of 8 years experience with emphasis on participating and leading projects within Medical Device QMS space

Knowledge and Skills:

• Strong knowledge of quality management systems and industry related regulations (FDA 21 CFR 820, ISO 13485, MDSAP, ISO 9001).

• Strong interpersonal skills including decision making, persuasion, effective communication, objectivity, assertiveness, and thoroughness.

• Hold self and others accountable to deliver on commitments.

• Ability to implement processes and systems.

• Excellent ability to apply a systematic and analytical approach to problem solving.

• Ability to create, write, and present material, adjusting to the level of the audience.

• Knowledge and experience in process analysis, root cause investigation and risk management.

• Ability to develop solutions and effectively collaborate with all levels of staff while maintaining an appropriate assertive style.

• Effective project management and organizational skills.

• Ability to influence without authority coupled with ability to work collaboratively and effectively communicate with peers and management across all functions. May function in a leadership or project leadership role.

• Will interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.).

• Considered Site / functional level Subject Matter Expert in assigned areas of Quality Systems.

• Software development experience within a regulated environment is preferred 

Work Environment: 

• Remote

This position is a temporary assignment. This position will support remediation activities within MMS and is anticipated to last approximately through March 2026.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective pr